Status:
TERMINATED
The Intracerebral Hemorrhage Acutely Decreasing Arterial Pressure Trial II
Lead Sponsor:
University of Alberta
Conditions:
Intracerebral Hemorrhage
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The vast majority of intracerebral hemorrhage (ICH) patients present with elevated blood pressure(BP). Management of BP is controversial with two competing rationales. There is some evidence that hype...
Detailed Description
Study Design: multi-centre randomized open-label, blinded-endpoint trial of two different BP management strategies. This study is being conducted in the Emergency Departments and Stroke Units of Canad...
Eligibility Criteria
Inclusion
- Age ≥18 years
- Acute primary ICH demonstrated with CT scan, within 6 h of symptom onset.
- Two systolic BP measurements ≥140 mmHg recorded \>2 min apart to qualify for enrolment.
- Onset ≤ 24 h prior to randomization
Exclusion
- Contraindication to BP reduction i.e., severe arterial stenosis or high-grade stenotic valvular heart disease
- Indication for urgent BP reduction i.e., hypertensive encephalopathy, or aortic dissection
- Definite evidence that the ICH is secondary to underlying cerebral or vascular pathology, i.e., AVM, aneurysm, tumour, trauma, vasculitis, or hemorrhagic transformation of an ischemic infarct
- Previous ischemic stroke within 90 days of current event NB: Prior ICH is not an exclusion criterion
- Patients with suspected secondary cause of ICH.
- Planned surgical resection of hematoma NB: Extraventricular Drain placement is not an exclusion criterion
- Contraindication to CT perfusion imaging (i.e. contrast allergy, metformin use or Creatinine \>160 μmol/l)
- Patients with pre-existing disability and dependence (defined as a pre-morbid modified Rankin Scale score ≥3) will be excluded
- Patients with life expectancy \<6 months due to pre-morbid conditions/terminal illness
- Patients with known definite contraindications to MRI (pacemaker, ferrous metallic foreign body)
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2021
Estimated Enrollment :
142 Patients enrolled
Trial Details
Trial ID
NCT02281838
Start Date
August 1 2011
End Date
December 1 2021
Last Update
November 6 2024
Active Locations (2)
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1
University of Alberta
Edmonton, Alberta, Canada, T6G 2B7
2
Ottawa Hospital Research Institute
Ottawa, Ontario, Canada, K1Y 4E9